Building the evidence base for appropriate and efficient implementation of emerging genomic tests for disease management and screening

Active Project Grant Awarded Last action

Award ID
R01HG011792
Recipient
Awarding agency
Obligated
$11,080,101

Award facts

Assistance listing
93.172 Human Genome Research
Completion date 92% complete
Originally
Funding
  • $10,126,969.00 Federal
  • $953,132.00 Non-federal
Place of performance
San Francisco, CA 94158, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Payer coverage and economic value continue to be critical factors in determining whether genomic medicine is appropriately and efficiently implemented into clinical care and health policies. However, genomic tests are now emerging that present particularly difficult challenges for coverage and value determinations because they (a) will be used for screening and early detection in asymptomatic populations in addition to disease management in patients with a condition, and (B) use less-transparent methods, such as algorithmic scores, to establish linkages between genetic markers and disease. Our objective is to assess payer coverage decisions and the economic value of two types of emerging genomic tests for disease management and screening: cell-free DNA tests (CFDNA) and tests based on polygenic risk scores (PRS). The specific aims are: aim 1: examine which CFDNA and PRS tests are covered and why using (a) systematic evidence reviews of payer coverage policies and (B) structured interviews with payers on how they consider evidence and make coverage decisions. Aim 2: understand the economic value of CFDNA and PRS tests by taking a patient-centered approach, addressing key methodological challenges, and identifying gaps in evidence. Aim 3: compare evidence needs for payer coverage (aim 1) and economic value assessment (aim 2) across clinical scenarios and generalize our findings on evidence needs to other emerging clinical scenarios, considering patient access and stakeholder perspectives. This study will provide unique insights by examining multiple clinical scenarios and both coverage and economic value. All aims will be framed around the implications of our findings for patient access and disparities and consideration of stakeholder perspectives within a rapidly changing health care policy and delivery ecosystem. Study outcomes will identify key factors that determine positive coverage, what evidence is needed and how IT can be prioritized to develop appropriate coverage and value assessments, how patient- centered and advanced modeling approaches can be applied across clinical scenarios, and how coverage and value assessments can take into account patient access and disparities and diverse stakeholder perspectives. Study findings will contribute to the overarching objectives of systematic development of practices and policies that are appropriate, efficient, and equitable irrespective of whether the tests are covered or shown to have economic value. Our findings will be useful across stakeholders and will facilitate the development of policies and practices that will help patients have appropriate, efficient access to testing.

Transactions

Action Federal Non-federal Date
Amendment $0 $0
Amendment $852,472 $0
Amendment $74,995 $0
Amendment $74,995 $0
Amendment $843,691 $0
Amendment $843,691 $0
Amendment $843,691 $0
Amendment $937,434 $0
Amendment $937,434 $0
Amendment $937,434 $0
Amendment $937,434 $0
Amendment $937,434 $0
Amendment $953,132 $0
Original award $953,132 $953,132
Show all 14

Subawards

Subrecipient Amount Awarded
Executive Frameworks LTD In Year 4, EF will conduct an interview study with our Payer Advisory Board focusing on their views related two evolving paradigms of cancer screening, which… $183,184

Quick answers

Who received award R01HG011792?

R01HG011792 was awarded to The Regents Of The University Of California. San Francisco by National Human Genome Research Institute (National Institutes of Health) on July 8, 2021.

How much is award R01HG011792 worth?

$11,080,101 has been obligated on R01HG011792: $10,126,969 in federal funding and $953,132 in non-federal funding.

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